# K143635: KINETIS Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Mako Surgical
- Decided: Feb 20, 2015 after 60 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K810258 (1981). 56 ancestors in all.
No later device cites it as a predicate yet.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122160: Vanguard XP Knee System, Biomet Manufacturing Corp (2013) Summary page 5.
- K904448: Townley Total Knee (TTK), Biopro, Inc. (1991) Summary page 5.
- K926334: Axiom Total Knee Syst/Acl Retain Tibial Tray/Inser, Orthomet, Inc. (1994) Summary page 5.

## Indications for use
The KINETIS™ Total Knee System components are indicated for use in skeletally mature patients, with severe knee pain and disability, undergoing primary surgery for total knee replacement due to: Rheumatoid arthritis, osteoarthritic, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis Moderate valgus, varus, or flexion deformities. MAKO KINETIS™ Total Knee Replacement System components are indicated for use only with cement and are single use devices

Source page: https://510kreport.com/device/K143635
Methodology: https://510kreport.com/methodology